Kornimate/medical-research-clean huggingface dataset:
mri guided hifu for palliation of painful skeletal metastases in children

Conditions: Bone Metastases; Pain

Summary: the philips sonalleve mr-hifu system is expected to be effective in reducing pain intensity and/or reducing analgesic use in patients with painful uncomplicated bone metastases. no serious adverse effects are expected to result from this treatment.

the objective of this study is to determine if mr-guided high intensity focused ultrasound (mr-hifu) is an effective technique for alleviating the pain associated with bone metastases in paediatric cancer patients. this technique meant to be an adjunct therapy to the standard-of-care, which includes radiation therapy and chemotherapy. safety of the technique will be assessed through evaluating non-targeted heating using mri-based temperature mapping, and inspecting patients post-treatment for skin burns. or other signs of serious adverse events. efficacy of the technique will be assessed by evaluating/recording patients observed pain, quality of life, and pain medication usage both before and up to 3 months following treatment.

Eligibility criteria:
inclusion criteria: * able to give informed consent * weight \<140 kg (requirement to fit safely on top of the hifu table and inside mri * any radiologic evidence of bone metastases from any solid tumor (neuroblastoma, osteosarcoma, soft tissue sarcoma, or any other solid tumor metastases). * pain specifically at the site of interest (target lesion) * pain score for target lesion \>/ = 4 (indicating at least moderate pain) on an age-appropriate 0-10 point scale * target lesion in uncomplicated (ie no fracture / spinal cord compression /cauda equine syndrome/ soft tissue component) * available 3d mri image of the target lesion (or be able to obtain one in a clinically feasible amount of time as part of the baseline investigational stage.) * proposed mr-hifu treatment date \>/= 2 weeks from most recent treatment of target tumour or systems chemotherapy * proposed mr-hifu treatment date \>/= 1 week after administration of steroids for pain flare exclusion criteria: * unable to characterize pain specifically at the site of interest (target lesion). * pregnant / nursing females * target lesion is complicated (ie pressure of one fracture /spinal cord compression/cauda equine syndrome/soft tissue component) * target lesion \< 1cm from nerve bundles/ bladder/bowel * target lesion in contact with hollow viscera * target lesion located in skull, spine (excluding sacrum which is allowed) or sternum. * scar along proposed hifu beam path. * orthopaedic implant along proposed hiifu beam path or at site of target lesion. * active infection. * contradiction to general anesthesia or or gadolinium mri contrast agent. * requirement for general anaesthesia for non -hifu related mri scans.
transforming primary care payment in hawaii

Conditions: Diabetes

Summary: to design an innovative payment system that improves upon fee-for-service (ffs), incorporates behavioral economic principles, and improves work satisfaction among primary care physicians (pcps) while improving quality and reducing health spending at the state level. second, to test the incremental effectiveness of two additional interventions: (1) shared financial incentives between physicians and poorly controlled diabetes and (2) social comparisons ranking physicians on quality metric performance and total cost of care.

the goal of this project is to transform the hawaii medical service association (hmsa) primary care provider payment model to better incentive population health while bending the increasing trend of health spending in the state. primary care and overall spending patterns will be studied to lay the foundation for a more rationally designed model. this model deliberately shifts away from ffs and includes three components: 1) a risk-adjusted per-member, per-month (pmpm) base payment, 2) an enhanced quality incentive program with larger bonus amounts and 3) a total cost of care incentive at the po level. the aim is to build on the success of the alternative quality contract (aqc) program implemented by blue cross blue shield (bcbs) of massachusetts. while the aqc is used as a starting point, the study introduces and tests a number of innovations using concepts from behavioral economics. first, the move away from the ffs chassis to a pmpm-based capitated payment. second, 20% of the pmpm payment is at-risk based on metrics designed to increase engagement between hmsa and physicians and engagement with performance feedback. third, the number of metrics in the quality incentive program is drastically reduced from over 60 metrics to 10-12 per specialty. fourth, the scoring of quality incentives incorporates rewards for improvement, rather than exclusively attainment of thresholds, to activate physicians along the entire performance distribution. in addition to implementing the new payment model, the initial experiment will include a test of two additional behavioral concepts: social comparisons for physicians and a shared incentive for physicians and poorly controlled diabetics tied to improve glycemic control.

Eligibility criteria:
inclusion criteria: * hmsa physicians who are part of a provider organization that is participating in the payment transformation pilot. exclusion criteria: * any physician who is not part of a participating provider organization.
improvement assessment of coronary flow dysfunction using fundamental fluid dynamics

Conditions: Coronary Artery Disease

Summary: diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. in order to achieve this, two novel parameters, pressure drop coefficient (cdp), which combines flow and pressure readings and lesion flow coefficient (lfc), which combines anatomical details of the lesion with pressure and flow readings, are being investigated.

diagnosis of relative contributions of large artery blockages and microvascular blockages is very much needed in the treatment of coronary artery disease. in order to achieve this, two novel parameters, pressure drop coefficient (cdp), which combines flow and pressure readings and lesion flow coefficient (lfc), which combines anatomical details of the lesion with pressure and flow readings, are being investigated. the diagnostic parameters will be correlated with coronary flow reserve (cfr)values obtained using positron emission tomography (pet) imaging. they will also be correlated with fractional flow reserve (ffr).

Eligibility criteria:
inclusion criteria: * 18 years of age or above * patients referred to a stress test by a cardiologist * acute chest pain, as per patient input. * risk assessment with prior test results and/or previous history of known chronic stable cad. * borderline or discordant stress testing where obstructive cad remains a concern. * new or worsening symptoms- abnormal coronary angiography or abnormal prior stress imaging study. * coronary stenosis or anatomic abnormality of uncertain significance. * in absence of reliable diagnostic information from another imaging modality. exclusion criteria: * left ventricular ejection fraction less the 25% determined by gated spect imaging * non-dialysis dependent chronic kidney disease with baseline serum creatinine greater than 2.5 gm/dl. * history of type ii heparin-induced thrombocytopenia. * significant co-morbid condition that is medically unstable and would make coronary angiography prohibitive or contraindicated. * pregnant women. * incapacitated for consent

Keywords: reversible ischemia microvascular dysfunction
interferon gamma-1b by inhalation for the treatment of patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this research study is to evaluate the safety and effectiveness of interferon gamma-1b (ifn-g 1b) on lung function when given to patients with cystic fibrosis by inhalation (breathed into the lungs) three times a week for 12 weeks. the fda has not approved interferon gamma-1b for use with cystic fibrosis patients, which is the condition being examined in this study.


Eligibility criteria:
key inclusion criteria: * at least 12 years of age * diagnosis of cystic fibrosis with mild to moderate pulmonary impairment * must be receiving ongoing chronic treatment with tobi (inhaled tobramycin) or not receiving ongoing chronic treatment with tobi and no use of tobi or other inhaled antibiotic within 4 weeks prior to study drug administration· * other specific diagnostic indicators of cf and other factors must meet minimum requirements.

Keywords: cystic fibrosis pulmonary impairment
localization of microvascular dysfunction

Conditions: Acute Coronary Syndrome

Summary: microvascular dysfunction is an independent predictor of poor prognosis. such response in the culprit vessel is common even after successful revascularization. this study investigated whether the microvascular dysfunction differed between culprit and non-culprit vessels in patients with acute coronary syndrome (acs) who underwent percutaneous coronary intervention (pci).

the prospective study included 115 patients with acs. in this study, after successful pci, culprit and non-culprit intracoronary hemodynamic measurements were performed and repeated at 6-month follow-up. 13n-ammonia positron emission tomography (pet) was performed at 6-month follow-up visit to determine absolute myocardial blood flow (mbf). the resistance values of each vessel were calculated using the coronary pressure data and the mbf values obtained from 13n-ammonia pet data. such physiological measures were compared between culprit and non-culprit vessels in baseline and 6-month follow-up.

Eligibility criteria:
inclusion criteria: * individuals were eligible for inclusion if they underwent pci for acs, if the target lesion was found in the proximal or middle segments of a major epicardial coronary artery, and if the lesion was successfully treated with a coronary stent. exclusion criteria: * a previous infarction other than in the vessel of interest or a history of coronary artery bypass surgery, cardiogenic shock requiring inotropic support, chronic kidney disease requiring renal replacement therapy, hypertrophic cardiomyopathy, collateral flow to the target vessel greater than angiographic grade 1, or statin or ticagrelor use within 1 year.

Keywords: microcirculation
effects of pilates method and aerobic training in hypertensive subjects

Conditions: Hypertension

Summary: this study evaluates the effects of pilates method and aerobic training in hypertensive subjects. half of participants will be trained with pilates, while the other half will be trained with aerobic exercise during 8 weeks.


Eligibility criteria:
inclusion criteria: * subjects with high blood pressure controled by medication; * sedentary. exclusion criteria: * imc≥30 kg/m² * using beta blockers * smokers or that interrupted the routine less than 6 months * musculoskeletal diseases in evolution or with current symptomatic * rheumatological diseases * other cardiovascular disease * renal disease due to hypertension * endocrine, neurological, oncological, immunological, hematological and psychiatric diseases.

Keywords: pilates training aerobic exercises hypertension clinical trial
effects of xanthohumol on metabolic syndrome progression

Conditions: Metabolic Syndrome

Summary: a huge body of scientific evidence has suggested that xanthohumol (xan) consumption, a polyphenol present in beer, has a positive effect on energy metabolism. this compound is known for its antioxidant, anti-inflammatory and anti-cancer properties which confer potential to be used as a food supplement. nevertheless, xan lipophilic properties prevent the extensive use of this molecule as a functional food compound. the company ta-xan s.a.m. (wiesbaden, germany) has patented a method to overcome this solubility problem. so, the main aim of this study is to evaluate the effects of xan consumption on metabolic syndrome progression in individuals recently diagnosed.


Eligibility criteria:
inclusion criteria: * men and women, 25-65 years of age; * criteria for metabolic syndrome according to the 2005 revised ncep atp iii guidelines: * hdl-c \< 40 mg/dl ♂ and \< 50 mg/dl ♀; * triglycerides ≥ 150 mg/dl; * blood pressure ≥ 130/85 mmhg; * fasting plasma glucose ≥ 100 mg/dl; * waist circumference ≥ 102 cm ♂ and ≥ 88 cm ♀; * hba1c 5.8/6.0-6.4; * nonsmokers or no other tobacco use in the last 3 months; * willing to stop taking regular supplements including antioxidants for 2 weeks prior to study entry through conclusion of study; * willing to stop consumption of beer for 2 weeks prior to study entry through conclusion of study; * must be able to provide informed consent; * blood screen tests \[comprehensive metabolic panel (cmp), and lipid profile\] within normal limits or if outside normal limits, approved for participation at the discretion of the study physician. exclusion criteria: * have a significant acute or chronic coexisting illness, such as cardiovascular disease, chronic kidney or liver disease, gastrointestinal disorder, endocrine disorder, immunological disorder, metabolic disease, cancer, chemotherapy history, gluten intolerance, eating disorders, depression or any psychiatric condition, diabetes, or any condition which contraindicates entry in the study, according to the investigators' judgment; * currently taking prescription drugs other than oral contraceptives (over-the-counter medications are allowed upon review and discretion of the study physician); * consumption of more than the recommended alcohol guidelines (\> 1 drink/day ♀ and \> 2 drinks/day ♂); * consumption of high levels of beer; * pregnancy (as confirmed by urine pregnancy test) or planning to become pregnant before completing the study; * breastfeeding; * under uv therapy (e.g. psoriasis treatment), using uv tanning beds and unprotected sun exposure greater than 1 hour/day; * engaging in vigorous exercise more than 6 hours/week; * participation in other dietary study in the past 3 months; * had surgery in the last 3 months; * post-menopausal status.

Keywords: metabolic syndrome xanthohumol glucose metabolism dna damage
the effect of combined general/epidural anesthesia versus general anesthesia on diaphragmatic function

Conditions: Prostate Cancer

Summary: the aim of this study was to investigate whether robot assisted laparoscopic radical prostatectomy give rise to the impairment of diaphragmatic function postoperatively, and whether combined general/epidural anesthesia could provide better postoperative diaphragmatic function.

diaphragmatic dysfunction after abdominal surgery can result in extended hospital stay and increased medical costs, because it is related with atelectasis, lung collapse or pneumonia. the mechanism of diaphragm dysfunction is thought to be from not only direct injury to abdominal wall and viscera but inhibitory reflexes of phrenic activity. thoracic or upper abdominal surgery is suggested as a risk factor of postoperative diaphragm dysfunction, and perioperative analgesic modality is also known to affect diaphragm movements. but there has been no trial to investigate the effect of laparoscopic pelvic surgery such as prostatectomy on diaphragm movement. moreover, it is not clear if minimally invasive robot-assisted laparoscopic radical prostatectomy (ralrp) has any influence on respiratory and diaphragm functions.

Eligibility criteria:
inclusion criteria: * patients of over 18 years of age undergoing elective robot-assisted laparoscopic radical prostatectomy exclusion criteria: * patients with previous history of smoking, cardiopulmonary or neuromuscular disease or obesity (body mass index \> 30 kg.m-2)

Keywords: diaphragmatic dysfunction general anesthesia epidural anesthesia
safety, efficacy, and side effects study of interventional cryotherapy in the pleural space("ice pls")

Conditions: Cancer; Pleural Neoplasms

Summary: the purpose of this study is to evaluate the safety, efficacy, and side effects of the cryospray ablation(tm) system (csa(tm) system) to treat neoplastic lesions on the parietal pleural surface.

the proposed study is a pilot study consisting of an estimated 10 subjects with biopsy-proven metastatic cancer in the parietal pleural surface treated with cryospray at dye marked metastatic foci. initial treatment dosimetry will be up to 3 cycles of 10-40 second sprays. if necessary, dosimetry changes may occur after 3 subjects are treated and observed. it is unknown if dosimetry will need to be increased to enhance effectiveness. the pi may increase dosimetry by 1 cycle after each subject is treated and observed as a conservative approach to efficacy determination. if disease exists bilaterally, only one side will be sprayed.

Eligibility criteria:
inclusion criteria: * 18 years of age * deemed a candidate for cryotherapy based on physician physical or medical history review * deemed operable based on institutional criteria * able to sign informed consent * documented lung or other visceral cancer with pleural involvement. * wbc \> 4,000/mm3, platelets \>100,000mm3 * physically well enough to undergo moderate sedation and pleuroscopy * female patients must be hcg negative * there should be direct evidence of disease progression despite treatment in previously treated patients exclusion criteria: * pregnant or nursing * planning to sire a child while enrolled in the study * known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines. * refusal or inability to give consent. * concurrent chemotherapy. * medical contraindication or potential problem that would preclude study participation * concurrent participation in other experimental studies * uncontrolled coagulopathy or bleeding diathesis * serious medical illness, including: * uncontrolled congestive heart failure * uncontrolled angina * myocardial infarction * cerebrovascular accident within 6 months prior to study entry

Keywords: parietal pleura neoplasms pleural surface pleural neoplasms lung cancer
phase i trial of 5-azacitidine plus gemcitabine in patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the primary objective is to determine the maximum tolerated dose (mtd) of azacitidine and gemcitabine in subjects with previously untreated and unresectable pancreatic cancer. also to determine the effect of azacitidine therapy on dna methylation in peripheral blood cells.

this is a phase i single arm study designed for subjects with newly diagnosed, unresectable pancreatic cancer who have received no prior chemotherapy, radiation therapy, or surgery with curative intent for pancreatic cancer.

Eligibility criteria:
inclusion criteria: * patient must have pathologically confirmed diagnosis of pancreatic adenocarcinoma * must have measurable disease as defined by recist. recist evaluation must have occurred within 4 weeks prior to study entry * must have newly diagnosed, unresectable disease and have received no prior chemotherapy, radiation therapy or surgery with curative intent for pancreatic cancer * karnofsky performance status of greater than or equal to 70% * other significant medical conditions must be well controlled and stable in the opinion of the investigator for at least 30 days prior to study day 1 * women of child bearing age must have negative serum pregnancy test prior to treatment exclusion criteria: * known central nervous system tumor involvement * evidence of other active malignancy requiring treatment * clinically significant heart disease * active serious systemic disease, including active bacterial or fungal infection * active viral hepatitis or symptomatic hiv infection. positive serology alone is not exclusionary * prior surgery with curative intent for pancreatic cancer * prior or current chemotherapy or radiation therapy for pancreatic cancer. palliative radiation for distant metastases (excluding metastases in the abdominal region) is allowed * breast feeding, pregnant, or likely to become pregnant during the study * known or suspected hypersensitivity to azacitidine or mannitol
nature video to improve older adult health: a feasibility study.

Conditions: Mild Dementia; Mild Cognitive Impairment

Summary: background: exposure to nature has a positive impact on a multitude of health-related outcomes such as stress, attention, recovery after surgery, and overall well-being. there is growing interest in determining the impact of vicarious nature experiences delivered through multimedia platforms on the well-being of persons at high risk for poor psychosocial outcomes, as is the case in older adults diagnosed with mild cognitive impairment (mci) or mild dementia. objectives/purpose: the primary purpose of this study is to assess the feasibility of providing an immersive nature-based multimedia experience to older adults with mci or mild dementia. a secondary purpose is to identify the potential health benefits of this intervention. methodology: a convenience sample of 40 older adults (65+ years old) with and without mild cognitive complaints will be recruited from a los angeles senior service partner. participation will include three visits. the first visit will include the consent process, cognitive testing, and questionnaire completion. the second and third visits will consist of a video session followed immediately by a group discussion regarding the content in the videos. the two video sessions will be administered in a randomized and counterbalanced manner one week apart. one video involves a 15-minute immersive nature-based experience and the other includes a 15-minute clip that presents emotionally "neutral" educational content. both sessions will be immediately followed by a group discussion of the content in the videos and how it relates to past experiences. outcomes and analysis: process evaluation data associated with recruitment, screening eligibility, involvement of personnel, assessment administration, and retention will be collected to determine overall study feasibility. additionally, selected assessments will be administered at each multimedia experience during key time points to examine potential short-term health benefits.


Eligibility criteria:
inclusion criteria: * speaks and understands english * mild cognitive impairment/mild dementia or normal cognition * minor complaints with thinking or memory * demonstrate the cognitive capacity to understand and consent to research procedures and to communicate his/her decision exclusion criteria: * self-reported phobias that could be triggered by nature-based videos
mono antiplatelet and colchicine therapy

Conditions: Acute Coronary Syndrome; Drug-Eluting Stents

Summary: the purpose of this study is to evaluate the efficacy and safety of aspirin-free, p2y12 inhibitor single antiplatelet and colchicine treatment in patients with acute coronary syndrome treated with drug-eluting stents.

after successful drug-eluting stent implantation for acute coronary syndrome, screening for study subject enrollment is performed. for those who submitted written informed consent, aspirin is stopped the day after the intervention, and colchicine 0.6mg once daily is started. the p2y12 inhibitor, prasugrel or ticagrelor, for single antiplatelet therapy remains. for the duration of hospital stay, platelet reactivity using verifynow test and c-reactive protein are measured. aspirin may be restarted at the discretion of the investigator based on results of the platelet function test. c-reactive protein is remeasured 30 days after the intervention. clinical follow-up is performed 30 days and 90 days after the intervention.

Eligibility criteria:
inclusion criteria: * successful pci with drug-eluting stent for nste-acs or stemi * provision of written informed consent exclusion criteria: * cardiac arrest or cardiogenic shock * age \ 90 years old * severe liver impairment * severe renal impairment (egfr \<30 ml/min/1.73 m2) * atrial fibrillation requiring anticoagulation therapy * intolerance of prasugrel, ticagrelor, or colchicine * history of intracranial hemorrhage * active bleeding

Keywords: platelet aggregation inhibitors colchicine